FLUOCINOLONE ACETONIDE oil

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Fluocinolone Acetonide (UNII: 0CD5FD6S2M) (Fluocinolone Acetonide - UNII:0CD5FD6S2M)

Disponível em:

Taro Pharmaceuticals U.S.A., Inc.

DCI (Denominação Comum Internacional):

Fluocinolone Acetonide

Composição:

Fluocinolone Acetonide 0.11 mg in 118.28 mL

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Fluocinolone acetonide topical oil is indicated for the topical treatment of atopic dermatitis in adult patients. Fluocinolone acetonide topical oil is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established. Apply the least amount of fluocinolone acetonide topical oil needed to cover the affected areas. As with other corticosteroids, fluocinolone acetonide topical oil should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks. Fluocinolone acetonide topical oil should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. Fluocinolone acetonide topical oil should not be used on the face, axillae, or groin unless directed by the physician. Application to intertriginous areas should be avoided due to the increased risk of local adver

Resumo do produto:

Fluocinolone acetonide topical oil is supplied in bottles containing 4 fluid ounces. It is labeled as Body Oil (NDC 51672-1356-8). Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep tightly closed.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
TARO PHARMACEUTICALS U.S.A., INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOCINOLONE ACETONIDE
TOPICAL OIL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR FLUOCINOLONE ACETONIDE
TOPICAL OIL, 0.01%.
FLUOCINOLONE ACETONIDE TOPICAL OIL, 0.01% (BODY OIL)
FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 1988
RECENT MAJOR CHANGES
Indication and Usage, Pediatric Patients with Atopic Dermatitis (1.2)
11/2007
INDICATIONS AND USAGE
Fluocinolone acetonide topical oil is a corticosteroid indicated for
the
topical treatment of atopic dermatitis in adult patients (1.1)
topical treatment of moderate to severe atopic dermatitis in pediatric
patients 3 months and older for
up to 4 weeks (1.2)
Limitations of Use:
Apply the least amount to cover affected areas. Discontinue when
disease is controlled. (1.3)
Do not use in the diaper area. (1.3)
Do not use on the face, axillae, or groin. (1.3, 6.2, 8.4)
DOSAGE AND ADMINISTRATION
Fluocinolone acetonide topical oil is not for oral, ophthalmic, or
intravaginal use. (2)
Adult patients: Apply to affected areas 3 times daily. (2.1)
Pediatric patients: Moisten skin and apply to affected areas twice
daily for up to 4 weeks. (2.2)
DOSAGE FORMS AND STRENGTHS
Fluocinolone acetonide topical oil, 0.01% (Body Oil) is supplied in
bottles containing 4 fluid ounces. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Topical corticosteroids can produce reversible HPA axis suppression,
Cushing's syndrome,
hyperglycemia, and glucosuria. (5.1)
Systemic absorption may require evaluation for
hypothalamic-pituitary-adrenal (HPA) axis suppression.
(5.1)
Modify use should HPA axis suppression develop. (5.1)
Potent corticosteroids, use on large areas, prolonged use or occlusive
use may increase systemic
absorption. (5.1)
Local adverse reactions may include atrophy, striae, irritation,
acneiform eruptions, hypopigmentation,
and allergic contact dermatitis and may be more li